NCT02875561

Brief Summary

The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 26, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

October 1, 2023

Enrollment Period

5.4 years

First QC Date

August 18, 2016

Results QC Date

August 14, 2023

Last Update Submit

October 30, 2023

Conditions

Vulvar Intraepithelial Neoplasia (VIN)

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Recurrence of Dysplasia

    Number of participants with recurrence of dysplasia time point 12 months

    12 months

Secondary Outcomes (3)

  • Number of Participants With Scarring

    6 weeks

  • Changes in Sexual Function

    Baseline (enrollment), 12 months

  • Changes in Mental and Physical Wellness

    Baseline (enrollment), End of Study (12 months)

Study Arms (2)

Sonopet Ultrasonic Aspirator

ACTIVE COMPARATOR

Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation

Device: Sonopet Ultrasonic Aspirator

CO2 Laser Ablation

EXPERIMENTAL

Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation

Device: CO2 Laser Ablation

Interventions

Sonopet Ultrasonic AspiratorDEVICE

To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation

Sonopet Ultrasonic Aspirator
CO2 Laser AblationDEVICE

To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation

CO2 Laser Ablation

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women 18-89 years old
  • Women diagnosed with high-grade VIN (diagnosed by pathology)
  • Women referred for vulva sparing treatment for dysplasia
  • Women available for follow-up of treatment for 12 months

You may not qualify if:

  • Women who are pregnant
  • Women with low-grade VIN dysplasia (diagnosed by pathology)
  • Women with vaginal intraepithelial neoplasia(VAIN)
  • Women requiring vulvectomy for treatment
  • Women unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Oklahoma

Norman, Oklahoma, 73019, United States

Location

Results Point of Contact

Title
Dr. Saketh Guntupalli
Organization
University of Colorado
saketh.guntupalli@cuanschutz.edu
303-724-2024

Study Officials

  • Saketh Guntupalli, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 23, 2016

Study Start

March 26, 2017

Primary Completion

August 11, 2022

Study Completion

April 20, 2023

Last Updated

November 18, 2023

Results First Posted

November 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)